目的：為做好參麥注射液安全性再評價工作提供數(shù)據(jù)參考。方法：滲透壓測定采用冰點測定法，對樣品原液及其稀釋液進行滲透壓測定，并計算與氯化鈉注射液滲透壓的比值；溶血率測定采用分光光度法，對樣品原液及其稀釋液進行溶血率測定。結(jié)果：滲透壓測定，樣品原液均為低滲溶液，滲透壓值在96～180 mOsmol/kg，1→4～1→8稀釋后與氯化鈉注射液滲透壓比可達0.9；溶血率測定，樣品稀釋倍數(shù)在小于1→16時，樣品均存在不同程度的溶血（溶血率＞5％），1→32倍稀釋時，溶血率均小于等于5％。結(jié)論：不同廠家生產(chǎn)的參麥注射液的滲透壓和溶血率均存在一定的差異，建議增加滲透壓和溶血率測定來控制其質(zhì)量。

Objective: To provide the data for re-evaluating the security of Shenmai Injection. Methods: Ice point method was used to determine the osmotic pressure of Shenmai Injection and its dilution solution. Ratio was calculated to NS. Spectrophotometry was utilized to measure the ratio of hemolysis. Results: All primary samples of Shenmai Injection were hyposmotic solution with osmotic pressure 96～180 mOsmol/kg. The ratio of the dilution(1→4 or 1→8)were up to 0.9. Different degrees of hemolysis occured when Shenmai Injection was diluted to less than 16 folds with the ratio of hemolysis more than 5%. But when Shenmai Injection was diluted to 32 folds, the ratio of hemolysis were less than 5%. Conclusion: There is obvious difference of osmotic pressure and hemolysis ratio among Shenmai Injection produced by different manufacturers. It was suggested that osmotic pressure and hemolysis ratio can be used to control the quality of Shenmai Injection.

浙江省中醫(yī)藥科技計劃項目:溶血率測定在中藥注射劑質(zhì)量控制中的應(yīng)用研究（NO.2007CA104）。